BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D
FDA premarket approval P010031/S481 · decided 2015-02-07
Approval details
- PMA number
- P010031
- Supplement
- S481
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-01-20
- Decision date
- 2015-02-07
- Days to decision
- 18 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE THE CLEANING PROCESS AT A SUPPLIER FOR THE CERAMIC ALUMINA INSULATOR SEAT IN FEEDTHROUGH ASSEMBLY.
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